madman
Super Moderator
Pathetic!
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Available in the link posted below.
On September 12, 2023, FDA issued a notice entitled, Determination That Oxandrin (Oxandrolone) Tablets, 2.5 Milligrams and 10 Milligrams, Were Withdrawn from Sale for Reasons of Safety or Effectiveness. FDA determined that Oxandrin (oxandrolone) tablets, 2.5 milligrams (mg) and 10 mg, were withdrawn from sale for reasons of safety or effectiveness. Thus, the agency will not accept or approve abbreviated new drug applications (ANDAs) for Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) has determined that Oxandrin (oxandrolone) tablets, 2.5 milligrams (mg) and 10 mg, were withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg.
Novitium Pharma LLC submitted a citizen petition dated April 6, 2022 (Docket No. FDA2022-P-0558), under 21 CFR 10.30, requesting that the Agency determine whether Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, were withdrawn from sale for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, were withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events.
Our records show that FDA’s Endocrinologic and Metabolic Drugs Advisory Committee met and discussed anabolic steroids in January 1984. The advisory committee unanimously concluded that there was no evidence of efficacy for oxandrolone.2
As communicated in the product labeling for Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, multiple safety warnings and precautions are associated with the use of this product including peliosis hepatis, sometimes associated with liver failure and intra-abdominal hemorrhage; liver cell tumors, sometimes fatal; and blood lipid changes that are known to be associated with increased risk of atherosclerosis.3 Per the product labeling, additional warnings with using this product include the risks associated with cholestatic hepatitis, hypercalcemia in patients with breast cancer, and increased risk for the development of prostatic hypertrophy and prostatic carcinoma in geriatric patients.4 Considering the safety concerns associated with the use of oxandrolone noted in the labeling, the Agency concluded that the benefit-risk profile of the drug product is unfavorable without substantial evidence to support effectiveness.
Based on a thorough evaluation of the information we have available to us and an evaluation of the latest version of the drug products’ approved labeling, we have determined that the drug products would not be considered safe and effective if they were reintroduced to the market today. New clinical studies would first need to be conducted to address the concerns described above. Thus, after considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, were withdrawn for reasons of safety or effectiveness. Accordingly, the Agency will remove Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, from the list of drug products published in the Orange Book per § 314.162. FDA will not accept or approve ANDAs that refer to this drug product.
Dated: September 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
Could not upload the PDF due to ongoing server error issues!
Available in the link posted below.
On September 12, 2023, FDA issued a notice entitled, Determination That Oxandrin (Oxandrolone) Tablets, 2.5 Milligrams and 10 Milligrams, Were Withdrawn from Sale for Reasons of Safety or Effectiveness. FDA determined that Oxandrin (oxandrolone) tablets, 2.5 milligrams (mg) and 10 mg, were withdrawn from sale for reasons of safety or effectiveness. Thus, the agency will not accept or approve abbreviated new drug applications (ANDAs) for Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) has determined that Oxandrin (oxandrolone) tablets, 2.5 milligrams (mg) and 10 mg, were withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg.
Novitium Pharma LLC submitted a citizen petition dated April 6, 2022 (Docket No. FDA2022-P-0558), under 21 CFR 10.30, requesting that the Agency determine whether Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, were withdrawn from sale for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, were withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events.
Our records show that FDA’s Endocrinologic and Metabolic Drugs Advisory Committee met and discussed anabolic steroids in January 1984. The advisory committee unanimously concluded that there was no evidence of efficacy for oxandrolone.2
As communicated in the product labeling for Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, multiple safety warnings and precautions are associated with the use of this product including peliosis hepatis, sometimes associated with liver failure and intra-abdominal hemorrhage; liver cell tumors, sometimes fatal; and blood lipid changes that are known to be associated with increased risk of atherosclerosis.3 Per the product labeling, additional warnings with using this product include the risks associated with cholestatic hepatitis, hypercalcemia in patients with breast cancer, and increased risk for the development of prostatic hypertrophy and prostatic carcinoma in geriatric patients.4 Considering the safety concerns associated with the use of oxandrolone noted in the labeling, the Agency concluded that the benefit-risk profile of the drug product is unfavorable without substantial evidence to support effectiveness.
Based on a thorough evaluation of the information we have available to us and an evaluation of the latest version of the drug products’ approved labeling, we have determined that the drug products would not be considered safe and effective if they were reintroduced to the market today. New clinical studies would first need to be conducted to address the concerns described above. Thus, after considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, were withdrawn for reasons of safety or effectiveness. Accordingly, the Agency will remove Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, from the list of drug products published in the Orange Book per § 314.162. FDA will not accept or approve ANDAs that refer to this drug product.
Dated: September 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
